Aseptic Filling Technician, Level IThe Aseptic Filling Technician, Level I will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the Aseptic Filling Technician, Level I will work hands on, under ISO7 and ISO5 areas with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set-up, documentation of tasks in cGMP logbooks and Batch Records, submitting samples, and performing filling operations aseptically in ISO5 areas. The hours for this shift are Monday - Thursday 5:00am - 3:30pmCore Responsibilities Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).Knowledge of current Manufacturing Practices (GXP) guidelines. Reports any accidents, incidents, and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace. Prepares for production run by reviewing the production schedule; identifying batch specific requirements; setting up the filling lines as per batch record instructions and applicable SOPs. Takes ownership of individual training plan. Responsible for reviewing all documentation including executed batch records and logbooks in "Real Time and Right First Time" and demonstrating error free documentation. Immediately reports errors or discrepancies to management. Obtaining equipment and required components for filling operations. Follows all steps outlined in batch records, ability to actively perform all tasks being required by the batch record/ SOPs. Ability to perform a batch record review in real time. Ability to operate aseptically in ISO 5 Cleanrooms. Customer/ Client Focus Ethical Conduct, respect for others, and solidarity. Technical Capacity to operate and troubleshoot processing equipment. Conscientiousness for work and documentation. Other duties and responsibilities as assigned.
Qualifications & Requirements:
High School diploma with 2 years -Pharma/Biotech Manufacturing Support and 1 year- within Clean Room environments and some technical certification is desired in related field.
Two years of experience working in ISO 5 areas.
Ability to handle sensitive information with a high degree of confidentiality.
Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, WordStrong organizational skills with the proven ability to prioritize.
Works with a sense of urgency while engaging and listening to experts.
Must be dependable and punctual.
Fluent in English both written and spoken.
Position TypeOn-SiteTravelNone
